Wise Choices in the Intensive Care Unit
NCT07013175
Acute Kidney Injury, Critical Illness
Stockholm, Sweden
View Trial DetailsNCT Number: NCT07262320
This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are:
* What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America? * How do outcomes differ across different countries in Latin America? * What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America?
The main aims of this study are to:
* Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America * Describe current epidemiology of AKI-RRT in Latin America * Compare processes of care and outcomes across different countries in Latin America * Provide data resources to facilitate and promote clinical research in AKI-RRT
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hospital Obrero No 2, Cochabamba, Bolivia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to hospital discharge or 90 days (whichever occurs first)
The variable is coded as 1 = deceased and 0 = alive by the time of hospital discharge
Time frame: From enrollment to ICU discharge or 90 days (whichever occurs first)
The variable is coded as 1 = deceased and 0 = alive by the time of ICU discharge
Time frame: From enrollment to 90-days post-ICU admission follow-up
The variable is coded as 1 = deceased and 0 = alive by the time of 90-day follow-up
Time frame: From ICU admission to death or ICU discharge (truncated at 90 days)
Length of stay will be calculated as the total number of full days between admission and discharge from the ICU. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer.
Time frame: From hospital admission to death or hospital discharge (truncated at 90 days)
Length of stay will be calculated as the total number of full days between admission and discharge from the hospital. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer.
Time frame: From enrollment to hospital discharge or 90 days (whichever occurs first)
Recovery will be defined as improvement in kidney function based on serum creatinine value at hospital discharge compared with baseline serum creatinine.
Baseline serum creatinine will be defined as either of the following (in order of priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation).
Patients who have serum creatinine <0.3 mg/dL higher than baseline at hospital discharge will be considered to have recovered renal function.
Time frame: From enrollment to 90-days post-ICU admission follow-up
Recovery will be defined as improvement in kidney function based of serum creatinine value at follow-up compared with baseline serum creatinine.
Baseline serum creatinine will be defined as either of the following (in order to priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation).
Patients who have serum creatinine <0.3 mg/dl higher than baseline at follow-up will be considered to have recovered renal function.
Time frame: From RRT initiation to hospital discharge or 90 days (whichever occurs first)
Patients will be classified as RRT-dependent if they continue to require any form of RRT at discharge. Patients who no longer require RRT will be classified as RRT-independent.
Time frame: From RRT initiation (day 0) to 90-days post-ICU admission follow-up
Patients will be classified as RRT-dependent if they continue to require any form of RRT at follow-up assessment. Patients who no longer require RRT will be considered RRT-independent.
Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
These include complications attributable to different types of anticoagulation (systemic unfractionated heparin, systemic low molecular weight heparin, regional citrate anticoagulation, other) used during RRT. Events include hemorrhage, heparin-induced thrombocytopenia (where relevant), citrate excess (where relevant), and citrate deficit (where relevant).
Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
These include infections associated with RRT. Events include catheter-related bloodstream infections, catheter insertion-site infections, and secondary peritonitis.
Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)
Procedural or mechanical complications occurring during RRT will be identified from medical records and bedside documentation. These include catheter malfunction (e.g., kinking, disconnection, malposition, migration, catheter tip adherence to vessel wall), circuit interruptions, circuit replacements, RRT downtime (where relevant).
Contact information is provided by the study sponsor or research team.
Javier A Neyra, MD, MSCS
CONTACT
Patricia J Busta Flores
CONTACT
University of Alabama at Birmingham
Other
Acronym: LATAM-AKID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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